Director of Regulatory Affairs

About Onnit:

Onnit is an Austin, TX-based health and wellness brand focused on encouraging a peak level of human performance through the best in nutritional supplementation, health-conscious foods, and unconventional fitness equipment and training. We are rapidly growing through support from professional athletes, medical practitioners, and our thousands of customers. We are proud of our Austin roots and have established a world-class gym next door to our headquarters. We’re excited to be named a Best Place to Work in Austin by Austin Business Journal, and we’d love to show you why.

About the Position:

As Director RA for ONNIT, you will be responsible to work with the VP QA/RA as one of the Company’s experts on regulatory compliance, providing direction, advice, and insights to appropriate stakeholders on existing, new, and emerging regulations as well as RA compliance and enforcement initiatives.

In support of the growing platform of products and formats spanning the business portfolios, you will bring expertise and operational experience in the dietary supplement category and have strong knowledge and experience in establishing regulatory processes and procedures. This expertise will enable ONNIT to continue to grow as a competitive and agile business in the categories that it operates within, enabling speed to market and competitive product claims, within global regulated industry segments.

As a senior voice for regulatory compliance, you will support the strategic internal and external-facing connections and industry organizations, ensuring ONNIT’s position as the industry leader in this area.

Responsibilities:

• With VP, implements and manages RA goals and objectives for ONNIT regulatory.
• Ensures that resources and activities are aligned with regulatory and business objectives.
• Communicates progress, problems, and plans as appropriate. Elevates issues requiring attention to VP QA/RA.
• Leads, under guidance of VP, RA activities to ensure regulatory compliance for existing products and new launches for Ingredients: GRAS status and safety, Product claims: claims substantiation and communication and Marketing materials: including webpages, social media, print material, and other media.
• Works with CMOs and R&D to create and maintain comprehensive Regulatory Dossiers for each product.
• Obtain and maintain 3rd party certifications as needed.
• Files applicable legal documentation including FDA 30-Day Structure/Function Claims Notifications, Commercial Co-Venture state filing, and others as needed.
• Collects documentation and works to understand formula and regulatory compliance to support international product registrations and launches.
• Keeps current with developing laws and regulations through participation in industry trade associations, conferences, trainings, and webinars.
• Analyzes, resolves, or assists in solving complex compliance and customer issues.
• Acts as a resource for Customer Service to provide support and compliant answers to technical questions.
• Works with CMOs to assure RA requirements are met.
• Writes/ Revises SOPs as required.
• Works with R&D to jointly design, implement, and sustain enabling processes, such as stage-gate deliverables/acceptance criteria for new product launches.
• Collects and publishes compliance metrics and reports trends for KPI.
• Comprehensive knowledge of laws and regulations in an FDA regulated environment, pertaining to the manufacture and marketing of dietary supplements.
• Demonstrated ability to lead in a collaborative environment with a positive leadership style and a hands-on approach that emphasizes teamwork, collaboration, influencing, motivating, and consensus and team building.
• Work with in-house and external legal counsel to resolve product compliance conflicts, and other issues when ambiguity exists in the regulations by applying risk management principles to ensure consumer and brand protection
• Provide RA guidance, risk assessment, and management throughout the product lifecycle: New Product Development and Commercial projects
• Provide coaching, mentoring, and training within RA team/department as required.
• Successfully lead/ facilitate internal and external agency audits as required.
• Perform management tasks for the team. These duties include conducting reviews, maintain team motivation and dividing the workload among members of the team.
• Participate as an effective member of cross-functional product teams.
• Meticulous attention to detail.
• Knowledge of nutrition and health sciences
• Progressive, successful management experience with ability to mentor and oversee experienced staff.
• Superior facilitation and communication skills both written and oral, including public speaking.
• Ability to work alone or as part of a team and willingness to "role up your sleeves" to get the job done.
• Demonstrated ability and track record of working in a deadline-driven environment and handling multiple concurrent assignments.
• Participate in external policy and advocacy to create, grow, and protect the business. Represent company on appropriate forums.

Requirements

• Bachelors or master’s degree in regulatory affairs, science, medical sciences, pharmacology etc.; or an equivalent combination of education and experience sufficient to successfully perform the key accountabilities of the job required.
• 8 years of direct US dietary supplement/OTC/Consumer Healthcare GMP/regulatory experience.
• In-depth Knowledge and experience on FDA and Health Canada quality & regulatory and applicable laws and regulations, as well as of cGMP standards.
• Proven regulatory advocacy skills with measurable deliverables in the dietary supplement space in US.
• Strong analytical, prioritizing, interpersonal, problem-solving, presentation, budgeting, project management (from conception to completion), & planning skills
• Strong verbal and written communication skills (including analysis, interpretation
• Ability to develop and maintain collaborative relationships with peers and colleagues across the organization, as well as internal and external stakeholders
• Ability to work well autonomously and within a team in a fast-paced and deadline-oriented environment.
• Self-motivated with critical attention to detail, deadlines, and reporting
• Excellent English written and verbal communication skills.

Benefits

• Full medical, dental, and vision benefits
• Basic Life Insurance
• 401(k) eligibility with company matching
• Flexible Vacation and time off policy
• Paid holidays
• Competitive compensation
• Tuition reimbursement
• Fringe benefits including free access to Onnit Academy gym ; co-pay healthy meals; among many others

EOE race/color/religion/sex/sexual orientation/gender identity/national origin/disability/veteran status